Senseonics 180-day Eversense XL implantable CGM System receives CE Mark approval; EU rollout expected in 4Q17 – September 13, 2017

Senseonics announced yesterday that the 180-day Eversense XL implantable CGM system has received CE mark approval, in line with timing shared on the 2Q17 call. In the press release, CEO Mr. Tim Goodnow comments that an EU launch is planned for 4Q17, though we’re not sure if he means UK in 4Q17, followed by the rest of the EU in 1Q18 as previously shared. This is a big win for patients who are interested in the implanted sensor, as it doubles the length of the indication up to this point. As CMO Dr. Lynne Kelley has pointed out, it can be used (on-label) more than 12 times longer than any other approved sensor (i.e., the 14-day wear FreeStyle Libre). EU uptake has been slow thus far, with >340 people implanted with Eversense outside of the pivotal trials (per Monday’s update). We wonder if a broader launch has been waiting on this indication, as it does really improve the benefit-hassle balance. The 180-day sensor wear data from PRECISE (the EU pivotal study) demonstrated a solid MARD of 11.6%, although only 40% of sensors successfully reported data for the total extended time period. We wonder if addressing the latter was a condition of approval, or perhaps product improvements have been made since the pivotal to improve long-term sensor functioning. How will accuracy and sensor longevity over 180 days look in the post-approval setting? If a sensor does not last 180 days, how hard will it be for patients to get an appointment and have a new one put in quickly? (i.e., limited time without CGM data)? How will reimbursement and pricing change for the 180-day version of Eversense – will Senseonics price on a per-day basis and capture more revenue at the same hardware cost?  

  • In the US, Senseonics still expects an FDA advisory committee panel to take place in the late fall, followed by hopes for approval in 4Q17 (this is for the 90-day Eversense). We’re not sure if and when the 180-day indication will be filed with FDA. We’re surprised by the potential for the meeting, since this is rare for devices.
  • We’ve seen a few patients walking around here at EASD with Eversense and have been impressed with the smaller size of the new on-body transmitter – it is slimmer and less clunky than gen one and definitely a form-factor win for the product. It will be fascinating to watch if patients choose it over Dexcom and Abbott – we could imagine systems choosing it, particularly if it negotiates a lower price.
  • Notably, 80% of those who have gone on Eversense are experienced CGM/Libre users (per 2Q17), and it will be interesting to see if the extended sensor wear indication serves to attract more CGM users or sensor-naïve patients.
  • Has 180-day accuracy improved since the original PRECISE pivotal trial? The accuracy in the 180-day EU pivotal trial (MARD: 11.6%) was notably diminished in the hypoglycemic range (<70 mg/dl), where MARD rose to 22%. That said, algorithm tweaks seemed to improve things in the 90-day PRECISE II data presented at DTM 2016 – an overall MARD of 8.8% and a mean average deviation (MAD) of 9.6 mg/dl below 80 mg/dl. Obviously MARD and MAD aren’t directly comparable, but an MAD of 9.6 mg/dl is far better than an MARD of 22%.


-- by Maeve Serino, Brian Levine, Adam Brown, and Kelly Close